Report

DelveInsight's " Acute Kidney Injury Market - Market Insights, Epidemiology and Market Forecast- 2032" report delivers an in-depth understanding of the AKI, historical and forecasted epidemiology as well as the AKI market trends in the United States, the EU-5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
AKI market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM AKI market size from 2019 to 2032. The report also covers current AKI treatment practice/algorithm, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.
Geography Covered
- The United States
- The EU-5 (Germany, France, Italy, Spain, and the United Kingdom)
- Japan
Study Period: 2019-2032

Acute Kidney Injury Disease Understanding and Treatment Algorithm

Acute Kidney Injury Overview
AKI is commonly defined as an abrupt decline in renal function, clinically manifesting as a reversible acute increase in nitrogen waste products measured by blood urea nitrogen (BUN) and serum creatinine levels over the course of hours to weeks. Signs and symptoms of AKI includes, nausea, vomiting, weakness, dizziness and, pain in lower back. Some patients are asymptomatic (no noticeable symptoms) and others may have generalized non-specific (not specific to kidneys) symptoms.
Acute Kidney Injury Diagnosis
The diagnosis of AKI is traditionally based on a rise in serum creatinine and/or fall in urine output. The laboratory assessment includes the measurement of Serum Creatinine Level, Urinalysis, renal biopsy and others.
Acute Kidney Injury Treatment
The treatment for AKI depends on the cause of the condition. Most people need to stay in the hospital during treatment and until the recovery of the kidneys. Some possible treatments include temporary hemodialysis, medicines to control the amounts of vitamins and minerals in blood, treatments to keep the right amount of fluid in the blood. There is no approved treatment for AKI, the current treatment practices use conventional therapies (vasopressor, diuretics, statins and others) and renal replacement therapies.




Acute Kidney Injury Epidemiology
The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Incident Population of AKI in Hospitalized Patients, Mortality Adjusted Incident Population of AKI in Hospitalized Patients, Stage-specific Incident Population of AKI and, Age-specific Incident Population of AKI in the 7MM market covering the United States, EU-5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2019 to 2032.
Key Findings
This section provides glimpse of the AKI epidemiology in the 7MM
Country Wise- Acute Kidney Injury Epidemiology
- The epidemiology segment also provides the AKI epidemiology data and findings across the United States, the EU-5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.
- The total Mortality-adjusted Incident Cases of AKI in the 7MM comprised of 6,470,038 cases in 2021 and are projected to increase during the forecast period.
- The total Mortality-adjusted Incident Cases of AKI in the United States is 2,210,647 in 2021.
- The US contributed to the largest incident population of AKI, accounting for ~ 34% of the 7MM in 2021.
- Among the EU-5 countries, Germany accounted for the highest number of AKI cases, followed by France, whereas Spain accounted for the lowest cases in 2021.
- In Japan, the total mortality-adjusted Incident Cases of AKI was 1,272,824 in 2021 and is anticipated to rise during the forecast period.
- The stage-specific cases of AKI includes stage I, Stage II and, stage III. Out of which maximum cases were reported in stage I AKI followed by stage II and Stage III.
AKI Drug Chapters
Drug chapter segment of the AKI report encloses the detailed analysis of AKI emerging (Phase-III and Phase II and Phase I/II) pipeline drugs. It also helps to understand the AKI clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.
Emerging Drugs
SB-101: Sentien Biotechnologies
SBI-101 is a combination product that integrates allogeneic Mesenchymal Stromal Cells (MSCs) within an extracorporeal, blood-contacting device. MSCs are a unique source of therapeutic secreted factors that modulate the immune-mediated inflammatory response to acute organ injury. In September 2021, Sentien Biotechnologies partnered with Biomedical Advanced Research and Development Authority (BARDA) to evaluate high dose cohort in Phase I/II trial of SBI-101 for treatment of AKI associated with sepsis.
RMC-035 (ROSgard): Guard Therapeutics
RMC-035 is a biological drug candidate (recombinant protein) administered to patients by IV infusion. In the future, it can be used as an in-hospital product for short-term treatment, for example, in connection with heart surgery and kidney transplantation. In April 2022, Guard Therapeutics announced that the Phase II study is called AKITA and is expected to provide blinded interim results by the first quarter of 2023 at topline results during the latter part of 2023.
OCE-205: Ocelot Bio
OCE-205's innovation emanates from its design as a mixed agonist-antagonist peptide selective for the Vasopressin 1a (V1a) receptor with no vasopressin 2 (V2) receptor activity at drug concentrations achieved while treating ESLD. In August 2022, the company announced that the US FDA has granted ODD to its lead candidate OCE-205 for the treatment of hepatorenal syndrome.
RBT-1: Renibus Therapeutics
Renibus' lead product, RBT-1, is a novel pharmacologic intervention combining stannous protoporphyrin and iron sucrose, induces a preconditioning protective effect on the kidney and other organs, upregulating the production of protective proteins to prevent post-operative complications following cardiothoracic surgery, including AKI, days in the ICU, time on ventilator, and hospital readmission rates. Recently, the company announced that an end of Phase II meeting with the FDA would take place in Q3 2022, and Renibus is planning to start a Phase III registration study by Q4 2022.
Note: Detailed emerging therapies assessment will be provided in the final report.

AKI Market Outlook
AKI pipeline with a novel mechanism of action and increasing incidence are major market drivers of AKI market. Additionally, the AKI pipeline is also expected to change the current dynamics of the market, which presently comprises biologics and molecules with new mechanisms of action.
Currently, there are no targeted pharmacotherapies approved for the treatment of AKI. At present, the therapeutic market size of AKI is mainly dominated by the use of Renal Replacement Therapy (RRT) and off-label drugs, which include various classes such as ACE inhibitors, Angiotensin II-Receptor Blockers (ARBs), Diuretics, and Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
Some patients develop stage 3 AKI and require Renal Replacement Therapy (RRT), and it is indicated for refractory hyperkalemia, volume overload, intractable acidosis, uremic encephalopathy, pericarditis or pleuritis, and removal of certain toxins.
The AKI pipeline possessed multiple potential drugs in late- and mid-stage developments to be launched shortly. Key players involved in robust research and development include SB-101: Sentien Biotechnologies, RMC-035 (ROSgard): Guard Therapeutics, OCE-205: Ocelot Bio, RBT-1: Renibus Therapeutics, and others are some of the major players that are going to alter the market dynamics in the coming years.
Key Findings
This section includes a glimpse of the AKI 7MM market.
- The total market size of AKI in the 7MM is USD 5,208 million in 2021 and is projected to grow during the forecast period (2022-2032).
- According to the estimates, the highest market size of AKI is from the United States, in 2021 and is anticipated to grow at a CAGR of 3.7%.
- Among the EU5 countries, Germany has the maximum revenue share in 2021 while Spain has the lowest market share.
- The market size of AKI in Japan is USD 1,051 million in 2021 which is expected to rise during the forecast period (2022-2032).

The United States Market Outlook
The total market size of AKI in the United States is expected to increase with a CAGR of 3.7% during the study period (2019-2032).
EU-5 Market Outlook
The total market size of AKI in EU-5 is expected to increase with a CAGR of 0.7% during the study period (2019-2032).

Japan Market Outlook
The total market size of AKI in Japan is expected to change with a CAGR of -1% during the study period (2019-2032).
Analyst Commentary
- The pipeline of AKI has diverse products targeting prophylaxis of AKI in several complications such as Sepsis, pre and post cardiac-surgery, and HRS-AKI
- Several biomarkers such as NGAL, Cystatin-C, etc. are being tried and tested to diagnose AKI. Validation of these new biomarkers could provide additional tools to detect the onset and severity of kidney injury
- Ocelot Bio's lead asset is OCE-205, is the only drug targeting the patients of Cirrhosis with Ascites, who developed Hepatorenal Syndrome-Acute Kidney Injury
- reCAP is the only drug in Phase III which is targeting AKI due to sepsis, once it is approved, it might capture a sizable market share because sepsis-AKI has a huge patient pool
- Currently Exponential Biotherapies is conducting Phase II trial for EA-230 only in Netherlands based on this we have assumed that the drug will launch first in the EU-5 followed by the US and Japan
AKI Drugs Uptake
This section focusses on the rate of uptake of the potential drugs expected to get launched in the market during the study period 2019-2032. The analysis covers AKI market uptake by drugs; patient uptake by therapies; and sales of each drug. For example- AM-Pharma's therapeutic candidate is a proprietary recombinant human Alkaline Phosphatase (recAP) constructed from two naturally occurring human isoforms of the AP enzyme. As per our analysis reCAP, drug uptake in the US is expected to be medium-fast with peak share of 16%, the drug may achieve its highest peak share in 6 years.
AKI Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase III, Phase II and Phase I/II stage. It also analyzes key players involved in developing targeted therapeutics.
Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition and merger, licensing and patent details for AKI emerging therapies.
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KOL- Views
To keep up with current market trends, we take KOLs and SME's opinion working in the domain through primary research to fill the data gaps and validate our secondary research. Some of the leaders like MD, Professor and Vice Chair Department of Critical Care Medicine and Director, Center for Critical Care Nephrology, PhD, chief executive officer at Renibus , CEO, Guard Therapeutics and others. Their opinion helps to understand and validate current and emerging therapies treatment patterns or AKI market trend. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.
Competitive Intelligence Analysis
We perform competitive and market Intelligence analysis of the AKI market by using various competitive intelligence tools that include-SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.
Scope of the Report
- The report covers the descriptive overview of AKI, explaining its causes, signs and symptoms, pathogenesis and currently available therapies.
- Comprehensive insight has been provided into the AKI epidemiology and treatment.
- Additionally, an all-inclusive account of both the current and emerging therapies for AKI are provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
- A detailed review of AKI market; historical and forecasted is included in the report, covering the 7MM drug outreach.
- The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM AKI market.
Report Highlights
- In the coming years, AKI market is set to change due emerging therapies in the pipeline, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
- The companies and academics are working to assess challenges and seek opportunities that could influence AKI R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
- As per DelveInsight's analysis the subtypes- specific of AKI include Stage I, Stage II and Stage III.
- Expected Launch of potential therapies, SB-101: Sentien Biotechnologies, RMC-035 (ROSgard): Guard Therapeutics, OCE-205: Ocelot Bio, RBT-1: Renibus Therapeutics and others might change the landscape in treatment of AKI.
AKI Report Insights
AKI Report Insights
- Patient Population
- Therapeutic Approaches
- AKI Pipeline Analysis
- AKI Market Size and Trends
- Market Opportunities
- Impact of upcoming Therapies

AKI Report Key Strengths
- Eleven Years Forecast
- 7MM Coverage
- AKI Epidemiology Segmentation
- Key Cross Competition
- Highly Analyzed Market
- Drugs Uptake

AKI Report Assessment
- Current Treatment Practices
- Unmet Needs
- Pipeline Product Profiles
- Market Attractiveness
- SWOT
- Attribute Analysis
Key Questions
Market Insights:
- What was the AKI market share (%) distribution in 2019 and how it would look like in 2032?
- What would be the AKI total market size as well as market size by therapies across the 7MM during the study period (2019-2032)?
- What are the key findings pertaining to the market across the 7MM and which country will have the largest AKI market size during the study period (2019-2032)?
- At what CAGR, the AKI market is expected to grow at the 7MM level during the study period (2019-2032)?
- What would be the AKI market outlook across the 7MM during the study period (2019-2032)?
- What would be the AKI market growth till 2032 and what will be the resultant market size in the year 2032?
- How would the market drivers, barriers and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights:

- What is the disease risk, burden and unmet needs of AKI?
- What is the historical AKI patient pool in the United States, the EU-5 (Germany, France, Italy, Spain, and the UK) and Japan?
- What would be the forecasted patient pool of AKI at the 7MM level?
- What will be the growth opportunities across the 7MM with respect to the patient population pertaining to AKI?
- Out of the above-mentioned countries, which country would have the highest incident population of AKI during the study period (2019-2032)?
- At what CAGR the population is expected to grow across the 7MM during the study period (2019-2032)?

Current Treatment Scenario and Emerging Therapies:

- What are the current options for the treatment of AKI? What are the current treatment guidelines for the treatment of AKI in the US and Europe?
- How many companies are developing therapies for the treatment of AKI?
- How many emerging therapies are in the mid-stage and late stage of development for the treatment of AKI?
- What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the AKI therapies?
- What are the recent novel therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
- What are the clinical studies going on for AKI and their status?
- What are the key designations that have been granted for the emerging therapies for AKI?
- What are the 7MM historical and forecasted market of AKI?

Reasons to buy
- The report will help in developing business strategies by understanding trends shaping and driving the AKI.
- To understand the future market competition in the AKI market and Insightful review of the SWOT analysis of AKI.
- Organize sales and marketing efforts by identifying the best opportunities for AKI in the US, EU-5 (Germany, Spain, Italy, France, and the United Kingdom) and Japan.
- Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
- Organize sales and marketing efforts by identifying the best opportunities for AKI market.
- To understand the future market competition in the AKI market.